FDA Spars With Recalcitrant Compounding Pharmacy, Again

For the third time in 15 months, the FDA is warning health care providers and consumers not to use drugs that were made by a Dallas compounder because the medicines may be contaminated. And the ongoing struggle between the agency and NuVision Pharmacy underscores the difficulties that beset the pharmaceutical supply chain despite a recently passed law designed to bolster safety.

In an alert issued late last week, the FDA took the unusual step of including a link to a 15-page inspection report that was completed July 16, showing numerous instances in which NuVision failed to investigate batches of various medicines after finding sterility problems. The FDA noted in its alert that these medicines had been marketed to the public as ‘sterile.’

The inspection follows two similar FDA alerts issued in April and May of last year about sterility problems with NuVision medicines. NuVision recalled one product. Last July, the FDA tried unsuccessfully to persuade NuVision to recall still more products. But NuVision defiantly posted a notice on its web site saying that it did not qualify as a drug manufacturer and was not required to follow FDA standards for manufacturing.

We left messages at NuVision seeking comment about the latest FDA alert and will update you with any reply that we receive.

The NuVision posture was cited last year by the agency as further need for Congress to pass legislation that would allow the FDA to bolster its regulatory oversight and legal options when encountering recalcitrant compounders. The FDA, at the time, was defending its actions in the wake of an outbreak of fungal meningitis in 2012 that was tied to a compounder and caused dozens of deaths.

The episode was called one of the worst public health crises in the U.S. in decades and cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority. Last fall, after months of recriminations, President Obama signed the Drug Quality and Security Act, which includes a section devoted to compounding oversight.

The law, effectively, creates two classes of compounders – one that voluntarily chooses to register with the FDA and another that may decline to do so. The first group is subject to certain conditions, such as meeting so-called good manufacturing standards, but the FDA hopes that the added requirements will give hospitals and physicians the confidence needed to purchase medicines from such compounders.

An FDA spokesman says that NuVision did not register with the FDA (here is the list). Even so, such compounders are still subject to warning letters, product seizures, injunctions and, possibly, criminal prosecution for violations of the Food, Drug & Cosmetic Act for distributing contaminated products, according to a recently issued FDA guidance on compounding.

And state boards of pharmacy are expected to continue to provide oversight. Gay Dodson, the executive director of the Texas Board of Pharmacy, tells us her agency has not taken any action against NuVision, but “we know what they’re finding.” She declined to comment when asked whether the board would investigate in light of the most recent FDA alert.

The flap is evidence that, while the law may give FDA added oversight, the voluntary nature of the registration process also means that cornering wayward compounders remains challenging.

“We’re still undergoing change says Gabrielle Cosel, manager of drug safety at Pew Charitable Trusts. Some compounding facilities will join that first category and others will change their business models and some other facilities will get into disagreements with FDA over what is allowed and what isn’t. This will have to shake out over time. A lot of work has to be done, but a lot of groundwork is in place.”

Comments (5 of 6)

The Bottom Line: If you ship it over a state line it just came under Federal, and thus FDA jurisdiction. The problem here is that the FDA has little to power on its own. In order to take any enforcement action they have to go ask the DoJ for the muscle.
This is an infinitely slow process. Just look at the meningitis deaths from 2012. The FBI is still investigating. The Mass compounding pharmacy (NECC ?) is almost out of business NOT because of their criminal actions that were noted by both the state and the FDA but because of CIVIL suits that have gone through the courts and their bankruptcy filing.

12:21 pm August 1, 2014

Nancy Abler wrote:

Texas is defiant against regulations and refuse to enforce them. The chemical plant in West Texas that exploded had obvious problems which were ignored. Many Compounders in Texas have several lab inspection failures and warnings that go unheeded. . This is a serious matter that is politically toxic to public safety. Compounders are designed to prepare formulas for special individual needs.. Instead they are providing a whole ESI industry with unapproved spinal treatments with steroids that are banned for spinal injections. This industry has slithered thru legal loopholes with no accountability.

7:39 pm July 24, 2014

Rocky wrote:

As usual with this topic, a bundle of mis-information and poor research.

For one, the link to the FDA inspection report is for Unique Pharmaceuticals, which IS an FDA-registered outsourcing facility. I suppose NuVision renamed itself after last years inspections.

Unique Pharmaceuticals DID indeed register as an "outsourcing facility" per the FDA link you provided. Additionally, regarding "FDA Guidance", the link you provided is for Section 503(a) compounders, NOT OUTSOURCING FACILITIES. The "FDA Guidance" for outsourcing facilities (Section 503(b) compounders) IS JUST "PROPOSED" GUIDANCE AND HAS NOT YET BEEN FINALIZED.

As for blaming the Texas Bd Of Pharmacy as others have written, the FDA has inspected these people several times. Per the new compounding law signed last year, the issue of oversight lies squarely with FDA. Your article SHOULD have pointed out that outsourcing facilities, per new Federal Law, DO NOT have to be a pharmacy at all, simply overseen by a registered pharmacist. Rather than settling the issue, the Law itself creates further confusion over who indeed DOES have jurisdiction. Congress wrote a cruddy Law - no surprise here - and instead of creating consistency it creates MORE confusion.

If you people want to write articles about compounding pharmacy, at least have the decency to do research and provide FACTUAL, WELL-RESEARCHED information please!

2:50 pm July 23, 2014

An Old Texan wrote:

I would hope that the care of the patient would win this battle. If the pharmacy would share their QAPI program and their follow up programs it would be a great gesture. However it appears that GREED is taking over. IF there is proof of contamination and nothing was or is being done, where are the lawyers. If this does not work, the news media is always looking for a good story. Let the public make the decision. And I pray that no harm is done to a patient because of this finding. However, if the worst should happen I ]would be glad to be a professional witness and shut this pharmacy down. Shame, Shame and more shame on NuVision that should be taking their blinders off and get a pair of bi-focals so the can see their potential harm. I thought ObamaCare was to prevent things like this from happening!

4:15 pm July 22, 2014

Sarah Sellers wrote:

I agree with the previous comment, but, the Board of Pharmacy is a "sharp end" on the supply side of multi-layered, error-prone decision-making pathway. That health professionals would knowingly step outside the contemporary U.S. (and essentially global) framework for drug approval, safety and oversight and fuel a supply-and-demand cycle for non-FDA approved drugs with little or no discussion of intended benefits and potential risks with individual patients is remarkable—in one finding alone, sterility failures were identified in 19 batches of medication.
On the demand side, the TX Medical Board Rules prohibit doctors from misrepresenting material facts that cannot be substantiated--this principle could be extended and adopted nationally to help guide the development of criteria to inform medical decision-making that may lead to the sometimes necessary, but hopefully rare, prescribing or use of unapproved medications that, by their very nature, impose greater risk burdens to patients.

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Pharmalot explores the fast-moving, complicated world that develops and markets medicines – and the drug makers that are attempting to replenish their pipelines while grappling with pricing and regulatory dictates, among many other challenges. Writer Ed Silverman has covered the pharmaceutical industry for nearly two decades and has closely followed the many hurdles facing drug companies as they move ideas from the laboratory to the medicine chest. He started Pharmalot while at The Star-Ledger of New Jersey and previously worked at New York Newsday and Investor’s Business Daily. Email Ed Silverman at ed.silverman@wsj.com, and follow him on Twitter @Pharmalot.